validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation). Ensure compliance of validation...
and vendors to achieve exceptional results. Responsible for managing the IQ, OQ, FAT, SAT and PQ efforts for new assembly...
scientific and technical understanding of laboratory testing methodologies, instrumentation, and IQ/OQ/PQ processes. Strong...
, traceability matrices, commissioning documents, IOQ/PQ, QSR, green tag, and blue tag Coordinate document templates, table...
/PQ and manufacturing process controls. Understanding of SPC, pFMEA, risk management, root cause analysis...
validation (IQ/OQ/PQ), Experience designing and building tools and machines. Knowledge, Abilities and Skills: Advanced CAD...
Responsibilities: Support process validations (IQ, OQ, PQ) and related documentation Assist with investigating quality issues...
equipment and commissioning. Start-up, installation, or qualification activities. Authoring IQ/OQ/PQ protocols...
comments/resolutions Coordinate resourcing for onsite walkdowns, SAT/commissioning/IOQ/PQ execution windows, and closeout...
device manufacturing experience. Experience supporting IQ/OQ/PQ validation activities. Familiarity with scientific molding...